Microbiology and the Cannabis Industry, is your Cannabis Testing Method Truly Validated?

Introduction

One of the fastest growing markets in the world, the production and sale of cannabis and cannabis infused products (CIP) is becoming a lucrative, legal industry. By the end of 2025, it is estimated that the global legal marijuana market will reach sales of ~$150 billion dollars1. In 2018, the legal marijuana industry grew by $10 billion in the US alone2. The rapid expansion can be attributed to the increase in legalization (and/or decriminalization) at the state level in the US, and at the national level globally (Canada, Uruguay, Netherlands, Spain, South Africa), but other factors, including an increase in the use of medical marijuana to treat more clinical conditions, and a demand from consumers for new products for adult use has also accelerated the market’s growth3. The expansion into new products, specifically foods, has resulted in an increased scrutiny of manufacturers. Similar to food producers, cultivators and distributors of cannabis and CIP must comply with regulatory requirements, establishing safety plans that certify the quality of their manufacturing processes and conduct routine laboratory screening of their products for specific microbial and chemical contaminates4.,5 However, unlike the food industry, there remains high uncertainty with some of the methods being used in the cannabis industry as the validation procedures used to certify them have been less then rigorous. In order to be utilized by food producers, method developers must validate their assays according to globally recognized standards. For the cannabis industry, the validation of methods for microbial contaminates has not been established, and methods currently being used may not be “fit for purpose” as the designs of these validations do not conform to globally accepted validation practices. The objective of this report will be to discuss the flaws in these validation designs (selection and use of live microorganisms, number of test replicates evaluated, use of surrogate strains, etc.) and provide guidance on improving study designs for future validations.